Alembic Pharmaceuticals announces USFDA Final Approval for Travoprost Ophthalmic Solution USP, 0.004%

Alembic Pharmaceuticals Limited (Alembic) today announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Travoprost Ophthalmic Solution USP, 0.004%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Travatan Ophthalmic Solution, 0.004%, of Alcon Pharmaceuticals Limited (Alcon). Travoprost Ophthalmic Solution USP, 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Alembic has a cumulative total of 110 ANDA approvals (97 final approvals and 13 tentative approvals) from USFDA.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.

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